On December 5, 2019 Screen Therapeutics LLC reported that is has formed a partnership with Immunaccel to focus on the discovery and development of next generation cancer immunotherapies (Press release, Screen Therapeutics, DEC 5, 2019, View Source [SID1234551982]).

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Screen Therapeutics will combine its immunology expertise, capabilities and know-how together with Immunaccel’s IP, know-how and proprietary cell lines to discover next generation cancer therapies targeting stromal interactions in the tumor microenvironment. This transaction is also part of a broader strategy for Immunaccel to leverage its intellectual property (IP) and know-how in developing human relevant translational platforms.

Underlying the company’s programs is a combination of proprietary ex vivo 3D platforms and well characterized human cell lines that enable the simulation of the tumor microenvironment. Screen Therapeutics will leverage these platforms to study the tumor stromal barriers that affect T cell activity and migration of immune cells in tumors.

"With approximately 30-40% of patients not responding to current immunotherapies, it is important to study the stromal factors that contribute to this phenomenon. Together with advanced imaging and complimentary technology platforms, we aim to simulate the various tumor immune microenvironments ex vivo, which will allow us to dissect the cross talk between immune cells, stromal cells and tumors with the goal of identifying novel targets and biomarkers," said Tonya Webb PhD, scientific co-founder on Screen Therapeutics.

"Since our inception, our mission has been to research, develop and advance synergistic translational research platforms to accelerate preclinical development timelines and advance innovative drug candidates into clinical trials," said Vik Subbu, Managing Partner of Equidis Ventures and CEO of Immunaccel. "The applications of ex vivo 3D platforms in cancer drug discovery have tremendous potential in providing human physiological relevance in identifying novel drug targets and biomarkers," he added.

On December 5, 2019 Select Medical Holdings Corporation ("Holdings") (NYSE: SEM), reported that Select Medical Corporation ("Select") has priced its private placement of $675 million aggregate principal amount of its 6.250% senior notes due 2026 (the "Additional Notes") as additional notes under the indenture pursuant to which it previously issued $550 million of 6.250% senior notes due 2026 (Press release, Select Medical, DEC 5, 2019, View Source;300970404.html [SID1234551981]). The offering has been upsized from the previously announced amount of $625 million. The offering is expected to close on December 10, 2019, subject to the satisfaction of customary closing conditions.

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Select intends to use a portion of the net proceeds of the offering, together with a portion of the proceeds from a proposed incremental term loan, and, if needed, available cash, to make an intercompany loan to Concentra, Inc. ("Concentra"), a joint venture subsidiary of Select, which will use the proceeds from such intercompany loan to repay in full all of Concentra’s outstanding term loans, and to pay related fees and expenses.

The Additional Notes and related guarantees are being offered in a private placement, solely to qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), or outside the United States to persons other than "U.S. persons" in compliance with Regulation S under the Securities Act. The Additional Notes and related guarantees have not been registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements.

This notice does not constitute an offer to sell the notes, nor a solicitation for an offer to purchase the Additional Notes, in any jurisdiction in which such offer or solicitation would be unlawful. Any offer of the Additional Notes will be made only by means of a private offering memorandum. This press release is being issued pursuant to and in accordance with Rule 135c under the Securities Act.

On December 5, 2019 Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported that the first patient has been successfully dosed in a Phase I clinical trial (CIBI110A101) of anti-lymphocyte activation gene 3 (LAG-3)recombinant fully human monoclonal antibody drug candidate (IBI110) in China (Press release, Innovent Biologics, DEC 5, 2019, View Source [SID1234551980]).

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CIBI110A101 is a phase I clinical study conducted in China to evaluate IBI110 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI110, either as monotherapy or in combination with Tyvyt (sintilimab injection), an anti-programmed cell death protein 1 (PD-1) antibody drug. The Phase Ia study will explore the safety, tolerability and efficacy of IBI110 as monotherapy.

IBI110 is a recombinant fully human anti-LAG-3 monoclonal antibody and will provide a brand new clinical solution to cancer patients. IBI110 can directly bind to LAG-3 on the surface of T cells, disturb the interaction between LAG-3 and MHCII, relieve the inhibiting effect of LAG-3 on T cells activation and enhance the anti-tumor immune response of T cells. Furthermore, the combination of anti-LAG-3 and anti-PD-1/PD-L1 may provide synergistic enhancement and improve the anti-tumor efficacy.

Professor Caicun Zhou, director of Oncology Department of Shanghai Pulmonary Hospital, said: "Although immune checkpoint inhibitors have shown gratifying progress in oncology therapy, we still confront many new challenges. With the increasing popularity of anti-PD-1/PD-L1 antibody, some patients have shown resistance to anti-PD-1/PD-L1 therapy. Meanwhile, the efficacy of anti-PD-1/PD-L1 therapy in its initial treatment of patients also needs to be further improved. Therefore, it has great significance to develop the next generation of tumor immune drugs, while LAG-3 is one of the most promising and prospective targets in tumor immunotherapy. We are looking forward to the clinical results of IBI110."

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, said: "LAG-3 is an important immuno-inhibitory receptor, but there is no approved antibody drug targeting LAG-3 so far. Currently, a series of relevant clinical trials is ongoing abroad, and the preliminary results have shown certain safety and anti-tumor effectiveness of anti-LAG-3 antibody either as monotherapy or combination with anti-PD-1/PD-L1 antibody. Notably, the combination therapies hopefully exhibited synergistic enhancement effect. Therefore, developing drugs targeting LAG-3 may provide more novel, comprehensive and effective treatments for patients. We will evaluate the potential clinical value of IBI110 and its combination therapy, and hope to ultimately benefit more patients."

About IBI110

IBI110 is an innovative IgG4κ recombinant fully human anti-LAG-3 monoclonal antibody developed by Innovent. As class 1 innovative drug, IBI110 can directly bind to LAG-3 and block its interaction with MHCII, thus activate and enhance the anti-tumor immune response of T cells. Furthermore, IBI110 may synergize with anti-PD-1/PD-L1 antibody to improve the anti-tumor efficacy. IBI110 may hopefully exert antitumor activity and delay the drug resistance in the form of monotherapy or combination with Tyvyt (sintilimab injection), which will provide more effective treatments for cancer patients.

About CIBI110A101

CIBI110A101 is a Phase I clinical study conducted in China to evaluate IBI110 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI110, either as monotherapy or in combination with Tyvyt (sintilimab injection), an anti-programmed cell death protein 1 (PD-1) antibody drug.

On December 5, 2019 US Oncology reported during the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, principal investigators from The US Oncology Network (The Network) and US Oncology Research will demonstrate detailed results from more than 20 studies covering topics including lymphoma, multiple myeloma, leukemia and more (Press release, US Oncology, DEC 5, 2019, View Source [SID1234551978]). The ASH (Free ASH Whitepaper) Annual Meeting, a leading scientific event in malignant and non-malignant hematology, will be held December 7-10 at the Orange County Convention Center in Orlando.

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"The future of cancer treatment is being cultivated at many practices in the community setting," said Michael Seiden, MD, PhD, president of The US Oncology Network. "I’m proud of the work being done by research investigators in The US Oncology Network. It’s amazing to see the quality of their research presented at ASH (Free ASH Whitepaper) every year. Their innovations are truly making a difference that impact cancer patients now and in the future."

Jeff Sharman, MD, medical director of Hematology Research for The US Oncology Network and director of Research at Willamette Valley Cancer Institute and Research Center (WVCI), will present an oral abstract titled, "ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL)," on Saturday, December 7 at 7:30am ET in Hall D, Level 2.

"BTK inhibitors have revolutionized the treatment of CLL," said Dr. Sharman. "This study led to the FDA approval of acalabrutinib in previously untreated CLL and presents compelling evidence of both safety and efficacy of the drug. With a second approved BTK inhibitor in CLL, there are now more available options for patients in need of therapy."

Additionally, Dr. Sharman will share his expertise during an education program on indolent lymphomas. His presentation titled, "Targeting CD20: Teaching an Old Dog New Tricks," will take place Saturday, December 7, 2:00pm-3:30pm ET as well as Sunday, December 8, 9:30am-11:00am ET in Tangerine 1 (WF1), Level 2.

"CD20 is an established target for the treatment of both lymphoma and chronic lymphocytic leukemia," said Dr. Sharman. "For nearly 2 decades, rituximab was an unequaled therapeutic in this space as the standard of care. With novel subcutaneous formulations, biosimilar molecules, second generation anti-CD20 antibodies, immunologically synergistic combinations and novel bispecific approaches, CD20-directed therapies are undergoing a dramatic change."

Christopher Yasenchak, MD, associate chair of Hematology Research for The US Oncology Network and hematologist with WVCI, is presenting an oral abstract titled, "Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged ≥60 Years," on Saturday, December 7 at 2:30pm ET in W224, Level 2.

"Elderly patients with Classical Hodgkin Lymphoma experience markedly inferior outcomes with conventional chemotherapy when compared to younger patients. This is due to differences in disease biology, increased rates of advanced disease, medical co-morbidities and treatment-related morbidity and mortality. As such, novel treatment strategies are needed," said Dr. Yasenchak. "The combination of brentuximab vedotin and nivolumab delivered in the frontline setting shows a high response rate and improved toxicity profile. This regimen may fill an unmet need for elderly patients unfit for conventional chemotherapy."

Furthermore, Robert Rifkin, MD, FACP, medical director of Biosimilars for McKesson, associate chair of Hematology Research and myeloma disease lead for The US Oncology Network, and hematologist with Rocky Mountain Cancer Centers (RMCC), will present "Daratumumab (DARA) Maintenance Therapy Improves Depth of Response and Results in Durable Progression-Free Survival (PFS) Following Dara Plus Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) Induction Therapy in Multiple Myeloma (MM): Update of the Lyra Study." The oral presentation will take place Monday, December 9 at 5:30pm ET in Hall E2, Level 2.

"This is an important study for multiple myeloma patients treated in the community setting as it gives them a treatment option that is relatively non-toxic that may increase the depth of response and achieve durable remissions," said Dr. Rifkin. "Additionally, DARA-Cy-Bord is safe and easy to manage."

Physicians with US Oncology Research worked with McKesson Data, Evidence and Insights investigators on a real-world evidence (RWE) study titled, "Treatment Patterns and Outcomes of Patients with Relapsed Follicular Lymphoma Treated with Idelalisib in a Community Oncology Setting." The poster presentation will take place Sunday, December 8, 6:00pm-8:00pm ET in Hall B, Level 2.

"This study evaluated patient profiles, treatment patterns and clinical outcomes among adult patients with relapsed or refractory follicular lymphoma who initiated treatment with Idelalisib within The US Oncology Network," said Presenting Author David Andorsky, MD, a hematologist with RMCC, a practice in The US Oncology Network. "These findings enhance available data on relapsed follicular lymphoma patient outcomes in real-world practice."

The full schedule of affiliated data presentations, including location and author information, can be found here. For more information or to interview a trial investigator, contact Claire Crye at 281.825.9927 or [email protected] or Edie DeVine at 209.814.9564 or [email protected].

On December 5, 2019 Zionexa, a radiopharmaceutical company specialized in the development and commercialization of in-vivo biomarkers for use in guiding targeted therapies in oncology, and PETNET Solutions Inc., a Siemens Healthineers company specializing in the manufacturing and distribution of positron emission tomography (PET) biomarkers, reported that they have entered into an exclusive agreement for the manufacturing and distribution of Zionexa’s new PET diagnostic drug, Fluoroestradiol (FES), which is pending approval by the Food and Drug Administration (FDA) (Press release, Zionexa, DEC 5, 2019, View Source [SID1234551977]).

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Fluoroestradiol (FES) is currently only approved for use in France for the characterization of estrogen receptor status in metastatic breast cancer.

"The Zionexa team is very excited to partner with PETNET in order to produce and distribute FES in the United States and ensure patients with metastatic breast cancer have access to this major innovation," said Bernard Landes, President & CEO Zionexa, "We are proud to work with the world-class team at PETNET to get this important diagnostic biomarker into the hands of clinicians. Studies have shown a high correlation between in-vitro immunohistochemistry assessment of estrogen receptor status and imaging findings using this biomarker. This new biomarker can provide clinicians with additional information to make more informed therapeutic decisions," said Peter Webner Zionexa CEO USA.

Barry Scott, Head of PETNET Solutions, added, "We are delighted to work with Zionexa to provide access to a new PET radiopharmaceutical that yields valuable clinical information to help physicians make treatment decisions. This agreement also allows PETNET to add to our portfolio of oncologic biomarkers and truly enable healthcare providers to practice precision medicine."’